This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with
co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study
protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary
Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of
PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD
with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted
therapy in this population has the potential to be of benefit for their OUD and maternal-
infant attachment.
This study will serve to explore the feasibility and safety of offering MDMA-assisted therapy
for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the
primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and
other assessments of opioid use disorder, effects on maternal-infant attachment, social
connectedness and other mental health outcomes are exploratory. The study will be conducted
at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In
addition to northern New Mexico being an epicenter of the current opioid use disorder
epidemic in the United States there is a long-standing history of multigenerational use of
illicit opioids in many communities of northern New Mexico. There are high rates of opioid
use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in
Albuquerque, Santa Fe, and surrounding communities.